Fenofibrate Impurity C; Fenofibrate Related Compound C; Fenofibrate EP Impurity C
Descrição
Fenofibrate EP Impurity C (CAS 217636-47-0) é uma impureza relacionada ao fenofibrato reconhecida como crítico para o controlo de qualidade. Caracteriza-se por propriedades físico-químicas bem definidas | solubilidade limitada em água e maior solubilidade em solventes orgânicos | e é detectável por HPLC com confirmação por LC-MS e RMN. A sua presença normalmente indica vias de degradação ou síntese incompleta e pode afetar pureza | potência e perfil de segurança do lote. O monitoramento por limites de especificação | estudos de estabilidade e validação de método é essencial. Estratégias de controlo incluem otimização de síntese | etapas de purificação e procedimentos analíticos validados.
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